Pragmatic Trials as an Additional Tool in the Evidence Building Toolbox

Excerpt

Though randomized controlled trials (RCTs) are the gold standard in medicine, extensive evidence shows their influence on clinical practice is often delayed, with the very aspects that increase internal validity of the studies limiting its applicability in real-world settings.^1‐4 In this issue of JGIM, Moin et al. examined the effectiveness of shared decision-making for diabetes prevention using a pragmatic trial design.⁵ Using a cluster-randomized design of 20 primary care clinics within a regional health system, Moin et al. found that participants receiving the shared decision-making intervention led by a pharmacist had higher uptake of efforts to increase prevention of diabetes, specifically use of metformin or participation in a local Diabetes Prevention Program (DPP).⁵ In addition, within the target population of overweight or obese adults with prediabetes, weight loss was greater at 12 month for intervention participants compared with a propensity score–matched control group.⁵ This article highlights a number of decisions that are necessary, and the real-world evidence that can result from a well-designed pragmatic trial. …